NCT00983060已完成2 期
A Randomized, Adaptive-design, Dose-finding Study to Assess the Antiviral Efficacy and Safety of NIM811 Administered in Combination With the Standard of Care (SOC) in Relapsed Patients Infected With HCV Genotype-1
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 7
- 主要终点
- To evaluate the safety and tolerability of NIM811 dosed daily for 4 weeks in combination with SOC
研究概览
简要总结
This is a study designed to identify a dose of NIM811 that has a good safety profile, is well tolerated when co-administered with SOC, and provides a clinically meaningful effect in viral load reduction compared to SOC alone. This information will be used to support doses selected for future studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
NIM811
Experimental
干预措施: NIM811 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo BID + SOC (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of NIM811 dosed daily for 4 weeks in combination with SOC
时间窗: 4 weeks
次要结局
- To explore the pharmacokinetics and pharmacodynamics of NIM811 given in combination with SOC in patients with chronic hepatitis C genotype-1(3 weeks, 5 weeks)
- To assess the percentage of patients achieving rapid virologic response (RVR) in patients treated with NIM811 in combination with SOC(4 weeks)
- To identify a dose of NIM811 which is safe and tolerated and produces in combination with SOC a clinically meaningful improvement over SOC monotherapy in antiviral response Time Frame: 4 weeks(12 weeks)
- To evaluate the effect of NIM811 given in combination with SOC in patients with chronic hepatitis C genotype-1 on sustained virologic response 12 weeks after cessation of treatment (SVR12)(12 weeks after cessation of treatment)
研究者
研究点 (7)
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